Kornimate/medical-research-clean huggingface dataset:
tolerability of a foaming facial cleanser and moisturizer spf 30 in a pediatric population (7-11) with acne prone skin.

Conditions: Acne Prone Skin

Summary: the purpose of this study is to determine the tolerability of cetaphil® dermacontrol™ foam wash and moisturizer spf 30 in pediatric subjects (7-11) with acne prone skin.

this was a open-label, single center study conducted in the united states that evaluated the tolerability of cetaphil® dermacontrol™ skin care products used at least once daily for 22 days in male and female subjects age 7 to 11 with acne prone skin. there were 4 visits during the course of the study: screening (within 7 days of visit 1), visit 1(baseline /day1), visit 2 (day 8), and visit 3 (day 22/exit). tolerability assessments were performed by a board certified dermatologist at all visits. subjects completed the baseline skin care regimen questionnaire at visit 1. hydration assessments were competed at visits 1, 2, and 3. a subject satisfaction questionnaire was completed at visit 3. adverse event assessments were conducted for all subjects at every clinic visit after informed consent/assent was signed.

Eligibility criteria:
inclusion criteria: * male and female subjects 7-11 years of age * subjects with acne-prone skin \[global severity of acne (gsa) score of 1 (almost clear) or 2 (mild) and any oiliness evaluation score or gsa score of 0 (none) with an oiliness evaluation score greater than or equal to 1 (mild)\] exclusion criteria: * subjects with any visible skin condition or facial hair that could interfere with the evaluations * subjects taking other medications, supplements, or non-prescription treatments that, in the opinion of the principal investigator/board certified dermatologist, could interfere with the test results including any regimen of steroidal/non steroidal anti-inflammatory drugs or antihistamines * subjects currently under the treatment for asthma or diabetes (insulin-dependent only) * subjects with abnormal pigmented vascular skin lesions, abnormal skin pigmentation, or body art (tattoos, permanent or temporary) on the face, which could interfere with subsequent evaluations of dermal responsiveness

Keywords: acne, pediatric
a study of qlf3108 in participants with advanced solid tumor

Conditions: Advanced Solid Tumor

Summary: this study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of qlf3108 and will make a preliminary assessment of the anti-tumor activity of qlf3108 in patients with advanced solid tumor.

this is a single-arm, open-label, phase 1, dose escalation and pharmacokinetics (pk) expansion study of qlf3108 in subjects with advanced solid tumor, to determine the dose-limiting toxicity (dlt), the maximum tolerated dose (mtd) and establish a recommended phase 2 dose (rp2d) of qlf3108. the purpose of this study is to describe the safety and tolerability, assess pharmacokinetics parameters and immunogenicity, and assess the anti-tumor activity of qlf3108 in subjects with advanced solid tumor.

Eligibility criteria:
inclusion criteria: 1. the volunteer has fully given informed consent to the study and voluntarily signed the informed consent form prior to trial. 2. ≥18 years old and body weight ≥40 kg; female or male. 3. histologically or cytologically documented advanced solid tumor; 4. failed to standard therapy or intolerance, or lack standard therapy advanced solid tumors. 5. eastern cooperative oncology group（ecog） performance status of 0 or 1. 6. life expectancy of at least 12 weeks. 7. adequate hematologic and end organ function. 8. female subjects who are not pregnant or not breastfeeding. a negative blood pregnancy test for females of childbearing potential within 7 days prior to first dosing. 9. male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study. exclusion criteria: 1. patients that have previously received cancer therapy within 4 weeks prior to the first dose of the investigational drug. 2. patient has received other investigational drug or other clinical trial treatment within 4 weeks prior to the first dose of the investigational drug. 3. active autoimmune disease that has required systemic treatment within 2 years prior to this study. 4. a live vaccine or live attenuated vaccine was administered within 30 days prior to the first dose of the investigational drug. 5. patients with adverse events(aes) from previous treatment that have not recovered to ≤1(ctcae 5.0）; or are unstable status. 6. severe concomitant medical condition for bowel obstruction, or implanted colon stent during screening period. 7. patients with a history of hiv positive or other immunodeficiency. or patients with the history of organ transplant or allogeneic bone marrow (excluding corneal transplantation). 8. patients with a history of psychiatric disorders, or epilepsy or dementia, drug or alcohol abuse, may impact patient completion of the study. 9. patients may interfere with the interpretation of study results as determined by the investigator, or are unable to participate in the whole study, or deemed unsuitable by the investigator.
diabetes virtual trek: obesity and diabetes prevention through science enrichment

Conditions: Type 2 Diabetes; Obesity

Summary: the purpose of this study was to evaluate the effectiveness of a school-to-home education program for it's ability to increase knowledge about, and ability to prevent type two diabetes in children and parents.

the study involved pre and post testing of parent's knowledge and behaviors relating to the prevention of type two diabetes, before and after a school based intervention designed to encourage school to home communication. parents/guardians and children, grades 2-6, from schools with high hispanic enrollment during the 2001-2005 school year were used for both comparison and intervention groups.

Eligibility criteria:
inclusion criteria: * elementary school children in grade 2-6 in intervention or comparison classes/schools

Keywords: parental parents prevention energy balance glucose regulation healthy lifestyles healthy families active living
greenwich lumbar stenosis slip study

Conditions: Spinal Stenosis; Spondylolisthesis

Summary: the purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). there are two types of operations that surgeons perform for this problem. some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). this study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.

there is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade i spondylolisthesis. the major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression. this multi-center, randomized, prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes.

Eligibility criteria:
inclusion criteria: * symptomatic lumbar spinal stenosis and single level grade i spondylolisthesis (3-14 mm) exclusion criteria: * history of previous lumbar spinal surgery in region of stenosis * gross spinal instability (defined as greater than 3 mm motion on flexion/extension studies) * serious medical illness (asa class iii or higher) * spondylolisthesis greater than 14 mm or associated with spondylolysis

Keywords: spinal stenosis lumbar spine decompression fusion spondylolisthesis prospective, randomized clinical trial
cognitive-behavioral weight loss treatment

Conditions: Weight

Summary: that a treatment using a cognitive-behavioral treatment for exercise and nutrition support will be associated with greater weight loss that a treatment of nutrition and exercise education.


Eligibility criteria:
inclusion criteria: * female * ages 21-60 * body mass index 30-40 kg/m2 exclusion criteria: * pregnancy * medications for a psychological disorder * contraindications for exercise
calypso knee system clinical study

Conditions: Osteoarthritis, Knee

Summary: a clinical study to evaluate the safety and effectiveness of the calypso knee system when used in subjects with symptomatic osteoarthritis of the medial compartment of the knee.

prospective, multicenter clinical study of the calypso knee system. 81 subjects were enrolled in this study. male or female subjects age 25 to 65 years, with a diagnosis of medial knee osteoarthritis and study knee pain with an overall womac pain score ≥ 40 (scale 0-100). the calypso group was investigated under two clinical protocols, cp0001 in the usa, and cp0002 in europe. both clinical protocols followed the same supporting protocols and plans, such as radiographic, statistical, clinical events committee (cec), etc. the results from the combined analysis have been reported in both nct03671213 (cp0001) and nct03838978 (cp0002).

Eligibility criteria:
inclusion criteria: 1. participants age - 25 to 65 years 2. body mass index (bmi) of \< 35, weight \< 300 lbs 3. knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment exclusion criteria: 1. symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee 2. knee ligament or meniscal instability 3. other bone or joint conditions such as rheumatoid arthritis, paget's disease, charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results
biometric recognition and rehabilitation assessment of lower extremity sports injury based on gait touch information

Conditions: Sport Injury; Osteoarthritis, Knee

Summary: the current common clinical methods cannot truly reflect the biomechanical status of the knee joint. based on the foot-knee coupling mechanism, the simple and practical dynamic gait touch information provided by the 3d force platform are closely related to the knee biomechanics. the purpose of this study is to investigate the disease feature recognition, computer-aided diagnosis and rehabilitation assessment based on the gait touch information related to lower limb injuries.

background: the current common clinical methods cannot truly reflect the biomechanical status of the knee joint. the three-dimensional gait analysis is the gold standard, but it is difficult to apply clinically. there is an urgent need for a clinically practical method to quantitatively evaluate the biomechanics of the knee joint under dynamic weight bearing. methods: 50 healthy volunteers, 450 sports injuries patients (including hip, knee, and ankle joint diseases) and 50 patients with degenerative osteoarthritis were recruited. 55 passive reflective markers were placed bilaterally on the body. lower extremity kinematics and dynamic plantar pressure during walking, jogging were collected. outcome evaluation indicators and statistical methods: the following indicators use repeated measurement two-factor analysis of variance: the left and right sides, different rehabilitation times are used as repeated measurement variables, to analyze the biomechanical changes of the lower limb joint biomechanics and gait touch information. a variety of machine learning methods (such as pca, svm, cnn, etc.) are used to analyze, and select the appropriate algorithm and parameters according to the learning effect. finally, this study will establish a machine learning models for computer-aided diagnosis, treatment, and rehabilitation assessment.

Eligibility criteria:
inclusion criteria: * patients with a certain sports injury (soft tissue injury or degenerative osteoarthritis) of a joint of the lower limb (hip or knee or ankle or foot). exclusion criteria: * cognitive impairment * other injuries affecting movement performance.

Keywords: sports injury gait touch information machine learning
determination of risk factors and mortality for pediatric chronic critical illness in turkey

Conditions: Critical Illness

Summary: it is predicted that the number of pediatric chronic critical illness increases similar to adult all over the world. the prevalence of pediatric chronic critical illness in turkey is unknown. the investigators aimed to evaluate the etiology, comorbid conditions, demographic data, prevalence, mortality and costs of these patient in intensive care units in turkey. in this multi-centered study, the investigators will retrospectively review the last 3 year of patients receiving treatment at the intensive care unit.

patients receiving acute critical cause of icu in the intensive care unit (icu) may be hospitalized for longer periods of time due to accompanying diseases or iatrogenic causes. this disease is called "chronic critical illness" (cci). cci is associated with prolonged acute mechanical ventilation, but there is no definition in the literature for newborns. pediatric cci is estimated to be similar to adults. in the united states, the number of cci is around 250,000, which is estimated to have doubled in the last 10 years. 50% of patients die in one year and much less than 12% recover. the estimated annual cost for the cci in the united states is over $ 20 billion. the prevalence of pediatric cci in turkey is unknown. in this study, it was aimed to investigate risk factors, mortality and cost of children with chronic critically ill and newborn patients in intensive care units in turkey.

Eligibility criteria:
inclusion criteria: * chronic critical iilness * the patients who are younger than 18 years old and staying in icu for at least 14 days. (the patients who is newborn and stay in the intensive care unit for 30 days in addition to prematurity). at least one of the additional criteria; * prolonged acute mechanical ventilation * tracheostomy * sepsis * severe wound (burn) or trauma * encephalopathy (post resuscitation syndrome, asphyxia, intra-cranial hemorrhage, metabolic disease, etc.) * traumatic brain injury * status epilepticus * post operative (cardiac and noncardiac) * neuromuscular disease (spinal muscular dystrophy, cerebral palsy, muscular dystrophy) exclusion criteria: * patients with a disease other than a chronic critical disease * patients older than 18 years

Keywords: prolonged acute mechanical ventilation
a study evaluating an integrated pharmacy digital diary and delivery strategy to increase prep use among msm and tgw

Conditions: HIV Prevention; Pre-exposure Prophylaxis (PrEP); Risk Reduction; Adherence, Medication

Summary: the prep 3d randomized controlled trial (rct) will study the effectiveness of the prep-3d app compared to standard of care for starting pre-exposure prophylaxis (prep), continuing prep, and adherence to prep.

the investigators will be testing a pharmacist-led model of prep delivery combined with mobile app-based prep support developed by the investigator's team to improve prep initiation and persistence. alto pharmacy is a full-service online pharmacy already using mobile and web apps to communicate with patients, providers, laboratories, and insurers to provide timely medication delivery. alto can provide prep prescriptions, order laboratory tests, and perform clinical referrals through a collaborative practice agreement (cpa) with sfdph that allows transfer of these responsibilities. the investigators have integrated online tools with alto pharmacy's technology platform to create prep-3d: digital diary and delivery, combining a tailored online support tool with the personalized service of a community pharmacy and the convenience of medication delivery. by removing the requirement for initiation and quarterly visits with a primary care physician for prep, the prep-3d model will expand access to prep visits (including for persons who choose not to go to their primary care provider for prep) and reduce burden on the health care system.

Eligibility criteria:
inclusion criteria: * age 18 years or older * assigned male at birth who reports sex with persons assigned male at birth * willing and able to provide written informed consent * hiv-uninfected by negative 4th generation hiv test during screening * owns a smartphone and has private access to the internet * able to understand, read, and speak english or spanish * lives in california * self-reported evidence of being at-risk for hiv acquisition, including at least one of the following in the past 6 months: * ≥ 1 episode of anal/vaginal sex with a male or transgender female partner; * diagnosed with a bacterial sexually transmitted infection (sti). * interested in taking daily tdf/ftc or taf/ftc prep * willing and able to receive prep prescriptions through alto pharmacy (e.g., no specific pharmacy required by health plan, such as kaiser hmo) * creatinine clearance \>30 ml/min * no contraindications to tdf/ftc or taf/ftc use exclusion criteria: * repeatedly reactive hiv test at screening or enrollment * signs or symptoms of acute hiv infection at screening or enrollment * currently enrolled in another hiv intervention study. * unable to commit to study participation for the duration of the study * any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Keywords: prep pre-exposure prophylaxis (prep) adherence hiv risk reduction mobile app pharmacy
comparative evaluation of two different radiosurgery

Conditions: Metastases to Brain

Summary: randomized double arm phase iii study to evaluate feasibility and safety of gamma knife radiosurgery and linac based (edge) radiosurgery in brain metastatic patients

this is a prospective double arm phase iii study to evaluate cerebral side effects following radiosurgery delivered by gamma knife perfexion and linac based edge. in particular our primary objective is to evaluate rate of symptomatic radionecrosis from the two different modalities of radiosurgery.

Eligibility criteria:
inclusion criteria: * age 18 - 85 years * 1 - 4 brain metastases * karnofsky performance status (kps) ≥70 * rpa 1 or 2 * histopathologically confirmation of primary solid tumor * estimated survival ≥ 3 months as gpa score * written informed consent exclusion criteria: * prior wbrt * age \> 85 years * kps \< 70 * rpa 3 * diagnosis of small cell lung cancer (sclc) or lymphoproliferative disease * use of avastin for at least 2 months after radiosurgery * pregnant women

Keywords: radiosurgery, brain, metastases
effects of lutein supplementation on cognition and mpod in multiple sclerosis patients-

Conditions: Multiple Sclerosis

Summary: the central hypothesis is that lutein supplementation will improve mpod and cognition. accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein supplementation on biological markers of lutein status and cognitive function among persons with ms.

a two-group parallel design will be employed whereby participants will be randomly assigned to one of 2 groups. the supplementation doses 20mg/d (group 1), and placebo (group 2) will be consumed daily by the participant for a 4-month period. pre-test and follow-up measures of lutein status and cognitive function will be assessed at baseline and at 4-month follow-up via laboratory visits.

Eligibility criteria:
inclusion criteria: * 18-64.9 years * self-reported relapsing-remitting ms (rrms) diagnosis * expanded disability status scale (edss) score between 0-3.5 * macular pigment optical density at baseline (mpod ≤0.35) * score ≤55 during the symbol digit modalities test (sdmt) * 20/20 or corrected vision * no presence of color blindness * no history of age-related macular degeneration * no history of epileptic seizures exclusion criteria: * under 18 years or over 64.9 years * ms diagnosis other than rrms * pregnancy * uncorrected vision * presence of color blindness * pdds score of 7 or more * prior diagnosis of age-related macular degeneration * history of epileptic seizures

Keywords: multiple sclerosis cognitive function lutein
the proactive support of labor study

Conditions: Obstetric Labor Complications

Summary: the duration of labor is decisive for maternal and fetal health. poor progression often results in tired mothers, bad experience, delivery complications and a demand for cesarean section in next pregnancy. proactive support of labor is a method originally from the netherlands. the main idea is to define start of active labor earlier than the traditional "3-4 cm opening of the cervix and regular contractions" to be cervix \< 0.5 cm in length, and 1 cm opening and painful contractions. from this point, it is expected to be a progress of 1cm/hour opening of cervix. if not, progress is supported by amniotomy or stimulation of contractions. this method is embraced by several clinics with great enthusiasm. however, there are no randomized controlled trials to prove that this method is better than others.


Eligibility criteria:
inclusion criteria: * spontaneous start of labor * nulliparous * term pregnancy * cephalic presentation exclusion criteria: * twins * breech presentation * given birth earlier * known uterine anomaly * insulin treated diabetes * preeclampsia * other serious medical conditions in mother or fetus

Keywords: delivery, obstetric uterine contraction cervix uteri
digestive biobank for exploring microbiota-host interactions

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Colorectal Cancer; Indeterminate Colitis

Summary: constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of inflammatory bowel disease or colorectal cancer.

inflammatory bowel disease (crohn, ulcerative colitis) and colorectal cancer are frequent affections and the microbiota plays a major role in their physiopathology involving the immune system. in this setting, the interplay between gut microbiota and brain is still unexplored. to evaluate the interaction of the microbiota and the immune system with the host in these two chronic diseases, we aim to create a prospective biobank. a small amount of tissue will be taken during surgery. a whole blood, plasma and stoll samples will also be taken from the patient. all samples will be anonymized.

Eligibility criteria:
inclusion criteria: * ulcerative colitis, crohn's disease or colorectal disease * digestive resection with useless tissue available * information consent signed exclusion criteria: - patients \< 18 years

Keywords: microbiota inflammatory bowel disease crohn's disease ulcerative colitis colorectal cancer post-operative cognitive disorders mood disorders immune system.